Bupivacaine With Epidural Volume Extension

The University of Alabama at Birmingham

Status and phase: Completed; Phase 3

Conditions: Spinal Anesthesia; Epidural; Anesthesia

Treatments: Drug: 10 mg Bupivacaine; Drug: 5 mg Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03110003

F1605020005

Details and patient eligibility

About

In this study the investigator will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures.

Full description

Due to risks to both the mother and fetus, neuraxial anesthesia - spinal, epidural, or combined spinal-epidural (CSE) - is preferred over general anesthesia for all obstetrical procedures. However, one downside to neuraxial anesthesia is the increased time patients have to stay in the post-anesthesia care unit (PACU) due to residual numbness from the neuraxial block. In this study, the investigators will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures. This will be accomplished by performing a CSE with: 1) injecting the local anesthesia in the spinal space; 2) injecting sterile saline into the epidural space to help increase the spread of the local anesthesia in the spinal space. The idea is that physicians will be able to use less local anesthetic due to getting a greater spread of medication. This lower amount of local anesthetic will lead to a decreased duration of the spinal block; therefore, it will significantly decrease PACU length of stay. This technique will be compared to our traditional dose of spinal anesthetic without EVE in the CSE. Both groups will have an epidural catheter in place to allow us to give any additional local anesthetic to keep the patient comfortable throughout the procedure if the spinal anesthesia begins to wear off. The aim of this study is to determine if low dose spinal bupivacaine in conjunction with EVE can decrease the PACU recovery time for short obstetric procedures while still providing an adequate surgical block.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing short obstetric procedure in the operating room requiring neuraxial anesthesia.

Exclusion criteria

• coagulopathy
• platelets <80,000
• allergy to local anesthetic or fentanyl
• previous spinal surgery
• spinal or intracranial mass
• history of lower extremity weakness

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

10 mg Bupivacaine

Active Comparator group

Description:

Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.

Treatment:

Drug: 10 mg Bupivacaine

5 mg Bupivacaine

Active Comparator group

Description:

Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.

Treatment:

Drug: 5 mg Bupivacaine